Material Safety Data Sheet North American Format

Transcription

1 Material Safety Data Sheet rth American Format Preparation Date 30-v-2006 Revision Date 22-Jan-2009 r Revision Number PRODUCT AND COMPANY IDENTIFICATION Product Name Common Name Chemical Name Synonyms Product Use Classification Supplier Inderal LA Long-Acting Capsules, Propranolol Hydrochloride Pharmaceutical product Cardiovascular Drug, Beta Adrenergic Wyeth Pharmaceuticals 64 Maple Street Rouses Point, NY USA. Telephone: Emergency Telephone Number Chemtrec USA, Puerto Rico, Canada Chemtrec International HAZARDS IDENTIFICATION Emergncy Overview This contains an active pharmaceutical ingredient that can affect body functions; handle with caution. Appearance Pharmaceutical capsule Physical State Solid Odor Odorless Potential Physical Hazards Powders and solids are presumed to be combustible. Potential Health Effects Eys May cause eye irritation. Skin May cause skin irritation. Inhalation May cause irritation of respiratory tract. Ingestion The most common effects may include low blood pressure/hypotension, low heart rate, lightheadedness, dizziness, paresthesia of hands, thrombocytopenic purpura, insomnia, lassitude, weakness, fatigue, catatonia, visual disturbances, hallucinations, vivid dreams, disorientation for time and place, short-term memory loss, emotional lability, and slightly clouded sensorium. Please see Patient Package Insert for further information. Target Organ(s Cardiovascular system, Kidneys. Carcinogenicity t listed by OSHA, NTP or IARC. Potential Environmental Effects There is no known ecological information for this product. Page 1

2 Revision Date Jan 22, 2009 Propranolol HC Extended-Release Capsules 3. COMPOSITION/INFORMATION ON INGREDIENTS Common Name CAS- Composition Propranolol Hydrochloride mg/ capsule Inactive Ingredients Eye Contact Skin Contact Inhalation Ingestion In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Take off contaminated clothing and shoes immediately. Wash off immediately with soap and plenty of water. If skin irritation persists, call a physician. Move to fresh air. Artificial respiration and/or oxygen may be necessary. If symptoms persist, call a physician. If symptoms persist, call a physician. Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person. Flammable Properties t flammable Extinguishing Media Suitable Extinguishing Media Use water spray, foam, dry chemical or carbon dioxide. Unsuitable Extinguishing Do NOT use water jet. Media Fire Fighting Hazardous Combustion Products Protective Equipment and Precautions for Firefighters Evacuate area and fight fire from a safe distance. Cool closed containers exposed to fire with water spray. In the event of fire and/or explosion do not breathe fumes. Carbon oxides, nitrogen oxides. In the event of fire, wear self-contained breathing apparatus and special protective equipment for fire fighters. Personal Precautions Refer to protective measures listed in Sections 7 and 8. Environmental Precautions Methods for Containment Methods for Clean-up Prevent product from entering drains. Local authorities should be advised if a significant spill cannot be contained. Take up mechanically and collect in suitable container for disposal. Clean contaminated surface thoroughly. Avoid formation of dust and aerosols. Handling For personal protection see Section 8. Handle in accordance with good industrial hygiene and safety practice. Skin should be washed after contact. Avoid formation of dust and aerosols. Page 2

3 Inderal Solid Products Storage special safety precautions required. Keep container tightly closed. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Common Name Exposure Guideline Propranolol Hydrochloride 50 mcg/m 3 Engineering Controls Apply technical measures to comply with the occupational exposure guideline. Local exhaust ventilation is needed for limited open handling or where aersols may be generated. Personal Protective Equipment Eye/face Protection Provide eye protection based on risk assessment. Skin Protection Wear nitrile or latex gloves. Wear protective garment. Respiratory Protection Base respirator selection on a risk assessment. General Hygiene Considerations When using, do not eat, drink or smoke. General industrial hygiene practice. Wash hands before breaks and at the end of workday. Other Limit access to only personnel trained in the safe handling of this material. Consult a health and safety professional for specific PPE, respirator, and risk assessment guidance. 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance Color Odor Threshold Pharmaceutical capsules Light blue cap/white body Physical State Odor Solid Odorless ph Specific Gravity Solubility Partition Coefficient (n-octanol/water) Water Solubility Evaporation Rate Vapor Pressure Soluble in water Boiling Point Autoignition Temperature Flash Point Method ne Melting Point Flammability Limits Upper Lower in Air Explosion Limits Upper Lower 10. STABILITY AND REACTIVITY Chemical Stability Conditions to Avoid Materials to Avoid Hazardous Decomposition Products Possibility of Hazardous Reactions Stable at normal room temperature. data available materials to be especially mentioned. ne under normal use. ne under normal use. Page 3

4 Inderal Solid Products 11. TOXICOLOGICAL INFORMATION The following effects are based on the Active Pharmaceutical Ingredient. Acute Toxicity Propranolol Hydrochloride LD50 Oral Acute Dermal Irritation Primary Eye Irritation Sensitization 466 mg/kg rat Multiple Dose Toxicity Proprano lol Hydrochloride Toxicologic Effect Dose Species/Study Length: See below Genetic, Reproductive, Developmental Toxicity Propranolol Hydrochloride Carcinogenecity Genetic Toxicity Long-term studies in rats revealed no evidence of carcinogenicity. Based on differing results from AMES tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of Propranolol in bacteria Reproductive Toxicity Studies in rats were found to have no effect on fertility and reproductive performance. Developmental Toxicity Studies in rats conducted indicated that this compound did not cause birth defects but can affect growth and development of fetus and newborns. Page 4

5 12. ECOLOGICAL INFORMATION The following effects are based on the Active Pharmaceutical Ingredient. Chemical Fate Information Ecotoxicity 13. DISPOSAL CONSIDERATIONS Waste Disposal Method Dispose of in accordance with local and national regulations. 14. TRANSPORT INFORMATION Transport Information This material is not classified as hazardous for transport. 15. REGULATORY INFORMATION USA Federal Regulations OSHA Regulatory Status This material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR ) SARA 313 Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals which are subject to the reporting requirements of the Act and and Title 40n of the Code of Federal Regulations, Part 372. SARA 311/312 Hazardous Categorization Acute Health Hazard Chronic Health Hazard Fire Hazard Sudden Release of Pressure Hazard Reactive Hazard Clean Air Act, Section 112 Hazardous Air Pollutants (HAPs) (see 40 CFR 61) This product does not contain any HAPs. State Regulations California Proposition 65 This product does not contain any Proposition 65 chemicals. State Right-to-Know Canada t classified WHMIS Hazard Class n-controlled Page 5

6 European Union In accordance with EC directives or respective national laws, the product does not need to be classified nor labeled. 16. OTHER INFORMATION Prepared By Format List of References Revision Summary Wyeth Department of Environment, Health & Safety This MSDS was prepared in accordance with ANSI Z See Patient Package Insert for more information. Revised January, 2009 to eliminate hydrochlorothiazide from MSDS Disclaimer: The information, data, recommendations, and suggestions appearing in this material safety data sheet (MSDS) and/or in materials regarding our active pharmaceutical ingredients (APIs) or products are based upon tests and data believed to be reliable as of the date of publication. NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER WARRANTY IS MADE WITH REGARD TO THE INFORMATION PROVIDED IN THE MSDS, REGARDING THE API, OR THE PRODUCT TO WHICH THE INFORMATION PERTAINS. Accordingly, Wyeth will not be responsible for any damages resulting from use of, or reliance upon, this information as conditions of use are beyond our control. Users are responsible for assuring the safety of their workers and safe operating conditions, and for determining whether the API or product is suitable for their particular purposes. Users shall assume all risks of their use, handling, and disposal of the API and/or product in accordance with all appropriate and applicable regulations. This information relates only to the API or product designated herein, and does not relate to its use in combination with any other API, material, product, or process. permission is granted for the use of any API or product in a manner that might infringe on existing patents. End of MSDS Page 6